Trial Information

- To show that a whole food extract of white button mushrooms (WBM) can inhibit
aromatase-induced estrogen biosynthesis in postmenopausal women who are breast cancer
survivors (BCS).

- To determine the optimal daily dose of WBM needed to induce aromatase inhibition of
estrogen biosynthesis in these patients.

- To determine the bioavailability of C-18 unsaturated fatty acids, which are thought to
moderate the anticancer effects of WBM.

Secondary

- To determine the safety and tolerability of WBM in humans via serial comprehensive
symptom questionnaires, pre- and post-treatment markers of bone metabolism, and pre-
and post-treatment comprehensive lipid panels.

- To explore potential alternate antitumor mechanisms, specifically the effect of WBM on
cytokines as well as innate and adaptive cellular immunity.

- To describe barriers experienced in recruitment of ethnically diverse subjects from the
community into a secondary prevention BCS trial utilizing a dietary supplement
intervention in an effort to enhance feasibility of a subsequent phase II trial.

- No major systemic infections or other major medical illnesses of the cardiovascular,
respiratory, or digestive system

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- More than 3 months since prior and no concurrent hormone-modifying medications,
including any of the following:

- Oral contraceptives

- Hormone replacement

- Selective estrogen receptor modifiers

- Other aromatase inhibitors

- Gonadotropic-releasing hormone modifiers

- At least 1 month since prior and no other concurrent mushroom extracts or DHEA as a
dietary supplement

- No concurrent therapy, except continued medications for unrelated illness that are
not excluded, and necessary medications for unrelated acute illnesses that may occur
during the study (e.g., cold, flu, or infection)

Name

Location

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